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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. CONTINUOUS GLUCOSE MONITOR

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DEXCOM, INC. CONTINUOUS GLUCOSE MONITOR Back to Search Results
Model Number MT20649-2
Device Problem Failure to Charge (1085)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/14/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(6) 2016 that on (b)(6) 2016 , the receiver would not charge. No additional patient or event information is available. The complaint device was returned for evaluation. The device was visually inspected and no defect was found. Functional testing was performed and the test failed. A review of the data log confirmed the customer complaint. A root cause was determined to be a bad receiver battery. Based on the findings of receiver would not charge, this issue has been upgraded from non-reportable to reportable.
 
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Type of DeviceCONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence drive
san diego CA 92121
Manufacturer (Section G)
DEXCOM, INC.
6340 sequence drive
san diego CA 92121
Manufacturer Contact
kipp durbin
6340 sequence drive
san diego, CA 92121
8582000200
MDR Report Key6372050
MDR Text Key68857786
Report Number3004753838-2017-17560
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation
Type of Report Initial
Report Date 11/14/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT20649-2
Device Catalogue NumberSTK-GL-113
Device Lot Number5210527
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/03/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/16/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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